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Zhongguo Zhen Jiu. 2010 Feb;30(2):97-101.
[Clinical study on acupuncture for treatment of chronic functional constipation]
Jin X, Ding YJ, Wang LL, Ding SQ, Shu L, Jiang YW, Huo WY.
The First Clinical Medical College, Nanjing University of TCM, Nanjing 210029, China.
OBJECTIVE: To discuss the effect of acupuncture for treatment of chronic functional constipation (CFC).
METHODS: Ninety cases were treated with acupuncture. The following two groups of acupoints were used alternatively once every other day. The acupoints in the first group were Tianshu (ST 25), Qihai (CV 6), Shangjuxu (ST 37) etc., and Zhongliao (BL 33), Xialiao (BL 34), Dachangshu (BL 25) etc. in the second group, electroacupuncture was used at Zhongliao (BL 33), Xialiao (BL 34), Tianshu (ST 25) and Shangjuxu (ST 37), once a day, 10 times constituting one course. The defecation frequency, difficulty degree of defecation, defecation time, endless sensation of defecation, stool quality and awareness of defecation were observed and the Patient Assessment of Constipation Quality of Life (PAC-QOL) was evaluated by constipation patients' diaries.
RESULTS: The scores of defecation frequency, difficulty degree of defecation, defecation time, endless sensation of defecation, stool quality, awareness of defecation and PAC-QOL were obviously improved after treatment (all P < 0.01). The total effective rate was 67.7% (61/90). The effect of acupuncture for chronic functional constipation in different dynamic mechanism was different. The effect of slow transit constipation (STC) was better than that of spastic pelvic floor syndrome (SPFS) (P < 0.05), and the effect of constipation caused by irritable bowel syndrome (IBS-C) was better than that of SPFS and relaxant pelvic floor syndrome (RPFS) (both P < 0.05). Fifty-two cases were effectively followed up. Three cases were cured, 6 cases were remarkably effective, 23 cases were effective and 20 cases were ineffective after 1 month of treatment. Three cases were cured, 5 cases were remarkably effective, 16 cases were effective and 28 cases were ineffective after 3 months.
CONCLUSION: The effect of acupuncture for CFC with exact etiology, disease location and classification diagnosis is definite, but different dynamic mechanism has different effect. The treatment programs for SPFS and RPFS need to be optimized to improve the therapeutic effect.
PMID: 20214063 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/pubmed/20214063
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Exercise may help soothe irritable bowels
By Amy Norton
NEW YORK ' Wed Jan 12, 2011 4:24pm EST
NEW YORK (Reuters Health) - People with irritable bowel syndrome may be able to find some relief by getting regular exercise, a small clinical trial suggests.
The study, of 102 adults with the disorder, found that those who were told to get some more exercise had better odds of seeing improvements in problems like cramps, bloating, constipation and diarrhea.
After three months, 43 percent of the exercisers showed a "clinically significant" improvement in their symptoms -- meaning it was making a difference in their daily lives. That compared with a quarter of the participants who maintained their normal lifestyle.
For people who are currently less-than-active, even a moderate increase in exercise may curb irritable bowel symptoms, according to senior researcher Dr. Riadh Sadik, of the University of Gothenburg in Sweden.
In an email, Sadik said the researchers had told those in the exercise group to get 20 to 60 minutes of moderate-to-vigorous exercise -- like brisk walking or biking -- on three to five days out of the week.
That's a level that is generally safe and achievable, Sadik said. On top of that, the researcher added, "it will also improve your general health."
About 15 percent of Americans have irritable bowel syndrome, or IBS, which causes bouts of abdominal cramps, bloating and diarrhea or constipation.
It is different from inflammatory bowel disease, which includes two digestive diseases -- ulcerative colitis and Crohn's disease -- that are believed to involve an abnormal immune system reaction in the intestines.
The exact cause of IBS is unknown, but people with the condition often find that they have certain symptom "triggers," such as particular foods, larger-than-normal meals or emotional stress.
The typical treatment includes diet changes, as well as anti-diarrheal medication and, for constipation, laxatives or fiber supplements. There's also some evidence that behavioral therapy and stress-reduction tactics help some people.
According to Sadik, exercise may be helpful for several reasons. Past studies have shown that it can get things moving along in the gut, relieving gas and constipation. (Vigorous exercise, however, may worsen bouts of diarrhea.)
Regular exercise may also have a positive influence on the nervous and hormonal systems that act on the digestive tract.
None of the participants in the new study, reported in the American Journal of Gastroenterology, were regularly active at the outset. The researchers randomly asked about half to begin exercising over a 12-week period, with advice from a physical therapist. The rest stuck with their normal lifestyle habits.
At the end of the study, the exercise group reported greater improvements on a standard questionnaire on IBS symptoms. They were also less likely to show worsening symptoms.
Of the exercise group, 8 percent had a clinically significant increase in IBS symptoms, versus 23 percent of the comparison group.
hat, according to Sadik, suggests that for a considerable number of people remaining sedentary may only worsen IBS.
"If you have IBS, then you can increase your physical activity to improve your symptoms," Sadik said. "If you stay inactive, you should expect more symptoms."
SOURCE: bit.ly/fMadZy American Journal of Gastroenterology, online January 4, 2011.
http://www.reuters.com/article/idUSTRE70B70R20110112
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Mindful Meditation Might Ease Irritable Bowel Syndrome
Related Health News
By Ellin Holohan
HealthDay Reporter
MONDAY, May 9 (HealthDay News) -- A simple meditation technique can help ease the torment suffered by people with a chronic bowel disease, a new study has found.
The research, done at the University of North Carolina at Chapel Hill, found that women with irritable bowel syndrome who practiced "mindful meditation" had more than a 38 percent reduction in symptoms, far surpassing a nearly 12 percent reduction for women who participated in a traditional support group.
Moreover, meditation helped reduce psychological distress and improved quality of life, the study found.
One of the study authors said the practice, based on a Buddhist meditative technique, "empowers" patients to deal with an illness that is difficult to treat.
"It's not easy to treat IBS [irritable bowel syndrome], even with the best standard medical approaches," said study co-author Olafur Palsson, an associate professor, clinical psychologist and research in the gastroenterolgoy department at the university. "It's chronic and, over time, it's hard to treat because it is complicated."
Mindful meditation helps practitioners relax by focusing on the moment, paying attention to breathing, the body and thoughts as they occur, without judgment.
"It's a different way of using the mind and being aware," said Palsson. He noted that more than 200 hospitals around the country offer the mindfulness meditation training program.
The technique takes discipline to learn, but "becomes second nature after a while," said Palsson, adding, "this is not a clinical treatment, it's more educational."
The findings were to be presented Saturday at Digestive Disease Week meeting in Chicago. Research presented at medical meetings should be viewed as preliminary because it has not been subjected to the scrutiny that typically accompanies publication in medical journals. In addition, the number of participants in the new study was small, and the findings need to be confirmed in larger studies.
Irritable bowel syndrome is a common chronic illness that can start as early as adolescence and become a lifelong condition. Symptoms include abdominal pain, cramps, diarrhea and constipation. Cases range from mild to severe. It differs from inflammatory bowel disease, a more serious condition with a similar name.
In the United States, the disease is more common in women and about one in six people has the condition, according to the National Institutes of Health. The condition is believed to stem from a genetic predisposition and is triggered by stress, a gastrointestinal infection or gastrointestinal surgery.
Treatments include anti-spasmodic medications to relax the colon, and drugs to reduce constipation and diarrhea. Patients are advised to avoid drinks and foods that stimulate the intestines, such as alcohol, caffeinated beverages, some grains, chocolate and milk.
But the disease varies from one person to another, and one regimen does not help everyone, according to health officials.
For the study, 75 women between 19 and 71 years old, with an average age of nearly 43 years, were randomly divided into two groups. One group participated in a mindfulness meditation training session and the other in a traditional support group, both for eight weeks.
Ahead of time, the groups rated the treatments' potential benefit, or "credibility," about the same, the study said.
But at the end of eight weeks, the meditation group had a 26.4 percent reduction in "overall severity of symptoms" compared to a 6.2 percent reduction in the support group. By the end of three months, the disparity persisted as improvement increased to a 38.2 percent reduction in symptoms for the meditation group vs. a 11.8 percent reduction for the therapy group, the study found.
The study authors also noted that mindful meditation was inexpensive and widely available.
One expert praised the research results as original and powerful.
"It's a small sample, but I'm impressed. It's not so easy to do this with treatments that are not well-defined," said Dr. Albena Halpert, a gastroenterologist and assistant professor of medicine at Boston University Medical School. "There have been other studies that looked at psychological treatment options, but this is the first looking at mindfulness, and the results are robust."
Halpert said she was surprised that both groups rated the potential benefit of the treatment option they were to receive equally.
"You can call it the placebo effect or whatever you want, but you have to believe in a treatment for it to work," said Halpert. "It's interesting that people would think it [mindfulness training] would have the same benefit as a support group."
More information
To learn more about mediation, visit the U.S. National Institutes of Health.
SOURCES: Olafur Palsson, Psy.D., clinical psychologist, research and associate professor, Division of Gastroenterology, University of North Carolina School of Medicine, Chapel Hill, N.C.; Albena Halpert, gastroenterologist, assistant professor, Boston University Medical School, Boston; May 7, 2011, presentation, Digestive Disease Week, Chicago
Copyright © 2011 HealthDay. All rights reserved.
This is a story from HealthDay, a service of ScoutNews, LLC.
(Broken Link Removed)
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Edited by lctuscher (09/26/14 03:13 PM)
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From Reuters Health Information
Mixed Evidence on Acupuncture for Irritable Bowel
By Amy Norton
NEW YORK (Reuters Health) Apr 25 - The research on whether acupuncture helps ease irritable bowel syndrome (IBS) has so far yielded mixed results, according to a new meta-analysis.
The review, published April 10th in the American Journal of Gastroenterology, found that in some trials, acupuncture seemed to work better than certain medications for IBS. In others, acupuncture was no better than a sham procedure.
"It's difficult to interpret the results of the review," said lead researcher Eric Manheimer, of the Center for Integrative Medicine at the University of Maryland School of Medicine.
For now, he told Reuters Health, "I think the evidence is equivocal."
In many cases, IBS can be managed with diet changes, along with anti-diarrheal medication or, for constipation, laxatives or fiber supplements. There are also a few drugs for the condition -- including alosetron (Lotronex) and lubiprostone (Amitiza). Doctors sometimes also prescribe low-dose antidepressants, anti-anxiety medications, or antispasmodics. But drugs are often limited in their effectiveness, and can have side effects.
Two non-drug options -- cognitive behavioral therapy and hypnosis -- have proven effective for some people in clinical trials. A fairly small number of studies have begun looking at acupuncture.
In their review, the researchers found five clinical trials that tested acupuncture against a sham procedure. None of the five showed that real acupuncture was superior at improving patients' ratings of their symptoms or quality of life.
On the other hand, five trials done in China did find that patients reported bigger gains from acupuncture when it was tested against certain medications -- which included certain anti-diarrheal, antispasmodic and anti-inflammatory drugs.
But there are limitations to both types of studies, Manheimer said.
With the trials that pitted acupuncture against drugs, the patients were recruited at hospitals for traditional Chinese medicine.
"So it's possible that patients' expectations played a role" in acupuncture's higher success odds, Manheimer explained.
With the sham-controlled trials, the study groups tended to be small, which may have limited their ability to pick up small benefits of true acupuncture, the researchers say.
There's also debate over what makes for a good sham version of acupuncture. In some studies, it may involve inserting needles in the skin at sites that are not considered acupuncture points according to traditional Chinese medicine. In others, it means using a dull needle that doesn't penetrate the skin.
"It's not clear that they (shams) are all inert," Manheimer said. Some sham acupuncture tactics may have biological effects that are close to the real thing. No one is sure how acupuncture works, but some research suggests the needle stimulation triggers the release of pain- and inflammation-fighting chemicals in the body -- even if the acupuncture doesn't strictly follow traditional principles.
In the future, Manheimer said it might be helpful to do trials that compare acupuncture against other treatments, but do it with a more general population of IBS sufferers than the Chinese studies used.
It would also be a good idea, he said, to measure patients' expectations going into the study. That way, researchers can look at whether people who expected to improve were more likely to report benefits from acupuncture.
"This is an interesting study," said Dr. Jeffrey M. Lackner of the University at Buffalo School of Medicine in New York, who was not involved in the work.
In the U.S., he noted, acupuncture would not be considered a "go-to" IBS treatment. As far as non-drug options, cognitive behavioral therapy (CBT) seems to have the best research evidence to back it up, according to Dr. Lackner.
The problem with CBT, though, is availability. "We really need to start developing IBS treatments that are more easily disseminated," he said. That could mean "self-help materials," like books or CDs, that teach people CBT principles.
As for acupuncture, Manheimer said that if patients do want to try it, safety and cost would be the other considerations. Acupuncture is generally considered safe, with side effects like bruising at the needle site. The cost can vary widely, but a session would typically start at around $100.
And many patients, Manheimer noted, may have to pay out of pocket.
SOURCE: http://bit.ly/IoaQnA
Am J Gastroenterol 2012.
http://www.medscape.com/viewarticle/762722
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Therapeutic heat and IBS
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Acupuncture Soothes Irritable Bowel Syndrome (IBS)
on 10 December 2014.
Acupuncture and moxibustion alleviate irritable bowel syndrome (IBS). Research confirms that acupuncture and moxibustion significantly reduce abdominal pain, diarrhea, and the ratio of abnormal stools. The research was conducted on patients with IBS-D, a type of irritable bowel syndrome characterized by insidious attacks of diarrhea. The total effective rate was 96.7% with many patients experiencing a complete recovery with no relapses. The positive patient outcomes for IBS-D patients suggest that additional research on IBS-C (constipation IBS) and IBS-A (alternating stool IBS) is warranted. Lower abdominal acupoints with four needles inserted.
Over 65% of patients in the study demonstrated "marked effect." The study's criteria for marked effect are: completely asymptomatic, normal frequency of bowel movements, normal stools, no relapse after three months. An additional 30% of patients experienced improvements. The criteria for "improvements" are significant reductions in symptoms and relapse within three months but only with mild symptom intensity.
As a standalone procedure, acupuncture demonstrated a 76.7% total effective rate including reductions in abdominal pain, diarrhea, and frequency of bowel movements. Acupuncture combined with moxibustion increased the total effective rate to 96.7%. The researchers note that "acupuncture combined with ginger and salt-partitioned moxibustion can obtain a remarkable effect for IBS-D. This integrative therapy is simple and convenient."
Biomedicine
The researchers note that the biomedical definition of IBS includes abdominal pain or discomfort with 2 out of 3 of the following symptoms: relief by defecation, changes in frequency of stools, changes in the form of stools (hard, loose, lumpy or watery). IBS may be further differentiated by greater than 3 bowel movements per day and urgent bowel movements. The symptoms occur for 12 weeks during a 12 month period but are not necessarily consecutive.
Traditional Chinese Medicine
The researchers note that IBS-D is differentiated into 3 patterns within Traditional Chinese Medicine (TCM) according to the Diagnosis and Treatment Protocol of Integrative Chinese and Western Medicine for Irritable Bowel Syndrome by Chen, et. al. Type 1 is liver qi stagnation with spleen deficiency. Symptoms may be triggered by emotional disturbances and include: diarrhea, abdominal pain, alleviation by defecation, and lower abdominal cramping. Secondary symptoms of type 1 IBS-D are: borborygmus, flatulence, mucus in stools, depression, sighing, irritability, poor appetite, and abdominal distention. Signs include a thin-white tongue coating and a wiry pulse.
Type 2 IBS-D is due to spleen and stomach deficiency. Diarrhea, especially after food intake, is a primary symptom along with loose stools, watery stools, mucus in stool, poor appetite, and abdominal distention after eating, gastric fullness and general digestive organ discomfort. Secondary symptoms include abdominal pain relieved by pressure, borborygmus, mental and physical fatigue, abdominal bloating, and reluctance to speak. Signs include a sallow complexion, a pale tongue with teethmarks, a white tongue coating, and a thready-weak pulse.
Type 3 IBS-D is due to spleen and kidney yang deficiency. Primary symptoms include early morning diarrhea, stools with undigested food, and abdominal pain with a cold sensation. Secondary symptoms include: coldness of the limbs, aching and weakness of the lower back and knees. Signs include a pale tongue with a greasy white coating and a deep-thready pulse.
Woman holding up copper handle acupuncture needles for display.
The study was conducted over a 4 year period. All participants in the study were screened for exclusion criteria. Patients with organic intestinal disorders were screened from participation using stool tests, fungal smear and colonoscopy.
Acupuncture
Acupuncture was applied to a set of primary and secondary points. Primary acupoints were:
Zhongwan (CV12)
Guanyuan (CV4)
Tianshu (ST25)
Zusanli (ST36)
Shangjuxu (ST37)
Pishu (BL20)
Dachangshu (BL25)
Secondary points were added for specific conditions:
Weishu (BL21) for weakness of the spleen and stomach
Ganshu (BL18), Xingjian (LR2) for liver qi stagnation with spleen deficiency
Shenshu (BL23) for yang deficiency of the spleen and kidney
The BL (bladder meridian of foot-taiyang) acupoints were needled with the patient in a prone position and the needles were removed upon the arrival of deqi. Next, patients assumed the supine position and the acupoints were inserted to 1 - 1.5 cun perpendicularly. Even reinforcing-reducing needle technique was applied using lifting and thrusting to achieve a deqi sensation of local soreness, distention, numbness, or a radiating sensation towards the abdomen. The needles were manipulated once every 10 minutes and were retained for a total of 30 minutes per session. In addition, the abdominal area was heated using a TDP heat lamp.
Moxibustion
Moxibustion was applied with patients in a supine position. A pillar of salt was poured onto acupoint Shenque (CV8). Next, ginger slices of 0.7 to 0.8 cm thickness and approximately 4 cm diameter were placed upon the salt pillar. Prior to placement, two toothpick sized holes were made through the ginger. Moxa cones of a 3 cm diameter and a 3 cm height were placed atop the ginger and were ignited. The moxa cone was replenished once during each session. Both acupuncture and moxibustion were performed once per day and 6 treatments made up one course of care. There was a 1 day interval between courses of care and all patients received 4 courses of care.
Additional Research
The results of the study indicate that combining acupuncture with moxibustion is significantly more effective for the treatment of IBS-D than acupuncture alone. Additional research confirms the efficacy of Traditional Chinese medicine. A meta-analysis published in the World Journal of Gastroenterology concludes, "Acupuncture exhibits clinically and statistically significant control of IBS symptoms." The study investigated all three types of IBS: diarrhea predominant (IBS-D), constipation predominant (IBS-C), and alternating (IBS-A). The researchers note "our meta-analysis of six randomized controlled trials suggests that acupuncture improves the symptoms of IBS, including abdominal pain and distention, sensation of incomplete defecation, times of defecation per day, and state of stool."
The researchers concluded that acupuncture is both safe and effective noting that, "No serious adverse events associated with acupuncture were reported in the articles." They aded that one study "showed that improvement in pain in IBS was positively associated with increased parasympathetic tone in the acupuncture group." This finding indicates that acupuncture regulates the parasympathetic nervous system.
One study in the meta-analysis was conducted at the University of York and was published in BMC Gastroenterology. This randomized controlled trial included 233 IBS patients who suffered from this condition for an average of 13 years. A total of 116 patients received acupuncture plus conventional care. This was compared with another group of 117 patients receiving only conventional medical care. The group receiving acupuncture plus conventional medical care demonstrated significantly superior clinical outcomes. The researchers concluded, "Acupuncture for irritable bowel syndrome provided an additional benefit over usual care alone. The magnitude of the effect was sustained over the longer term. Acupuncture should be considered as a treatment option to be offered in primary care alongside other evidenced based treatments."
Global Acceptance
Given the recent study of acupuncture combined with moxibustion and the meta-analysis published in the World Journal of Gastroenterology, it is reasonable to implement acupuncture in primary healthcare settings for the treatment of IBS. Dietetics ingredients for remedies. The are other sources supporting the use of acupuncture. The Mayo Clinic website notes, "Researchers have found that acupuncture may help improve symptoms for people with IBS." The IBS fact sheet from Johns Hopkins Medicine online notes, "Several small studies suggest acupuncture provides significant relief from chronic pain. In IBS patients, there are reports that acupuncture can relax muscle spasms and improve bowel function." IBS affects approximately 10 - 15% of the population. Scientifically based research now demonstrates that acupuncture may help patients with IBS.
The Healthcare Medicine Institute (HealthCMi) offers continuing education courses on the treatment IBS and digestive disorders. Online acupuncture CEU courses are valid for NCCAOM® PDA (national Diplomate), California Acupuncture Board, Florida Board of Acupuncture, Texas CAE, CTCMA, CAAA, Massachusetts acupuncture continuing education credit and more. In addition to acupuncture and herbal medicine courses on digestive concerns, the course Chinese Medicine Dietetic Remedies covers the treatment of IBS with dietetic treatments. A special steamed bun (Ba Zhen Gao) that helps patients with IBS, diarrhea, chronic dysentery, and colitis is presented. The recipe contained in the course material is:
"Powder Shan Yao (the main ingredient), Fu Ling, Dang Shen, Yi Yi Ren, Qian Shi, Bai Bian Dou and Lian Zi. Mix the powder with rice or wheat flour and add water to make a dough. Optionally, add powdered Dang Shen and Fu Ling. Sugar may be added for flavor. Make a steamed bun, bread or pastry. Originally, this steamed bun was served to children suffering from malnutrition."
An additional congee recipe is also presented in the dietetics course material. The Shan Yao Lian Zi Zhu recipe presented in the course materials is as follows:
"Zhu, translated as congee, is nutritious and well tolerated by children. Make a powder with Shan Yao (Chinese yam), Lian Zi, Qian Shi, Bai Bian Dou and Yi Yi Ren. Combine the powder with rice (Geng Mi), oatmeal or wheat to make a congee. Optionally, add Dang Shen, Fu Ling or both."
Browse healthcmi.com to learn more about the IBS online course materials. At HealthCMi, we are dedicated to research and education to promote greater health and understanding.
References:
Liu, Xiao-xia. "Moxibustion on Shenque (CV 8) improves effect of acupuncture for diarrhea-predominant irritable bowel syndrome." Journal of Acupuncture and Tuina Science 12, no. 6 (2014): 362-365.
Thompson WG, Longstreth GF, Drossman DA, Heaton KW,Irvine EJ, Müller-Lissner SA. Functional bowel disorders and functional abdominal pain. Gut, 1999, 45 (Suppl 2): Ⅱ43-47.
Chen ZS, Zhang WD, Wei BH. Diagnosis and treatmentprotocol of integrative Chinese and Western medicine forirritable bowel syndrome (IBS). Shijie Huaren Xiaohua Zazhi,2004, 12(11): 2704-2706.
Chen CY, Wang Y. Clinical effect of Trimebutine in treatment of irritable bowel syndrome. Zhongguo Xinyao Yu Linchuang Zazhi, 2003, 22(4): 199.
Voland C, Serre CM, Delmas P, Clézardin P. Plateletosteosarcoma cell interaction is mediated through a specific fibrinogen-binding sequence located within the N-terminal domain of thrombospondin 1. J Bone Miner Res, 2000, 15(2): 361-368.
Chao, Guan-Qun, and Shuo Zhang. "Effectiveness of acupuncture to treat irritable bowel syndrome: A meta-analysis." World Journal of Gastroenterology 20, 7 (2014): 1871-1877.
MacPherson H, et. al. Acupuncture for irritable bowel syndrome: primary care based pragmatic randomised controlled trial. BMC Gastroenterology 2012; 12: 150.
- See more at: http://www.healthcmi.com/Acupuncture-Continuing-Education-News/1405-acupuncture-soothes-irritable-bowel-syndrome-ibs#sthash.EIE2ESNr.dpuf
http://www.healthcmi.com/Acupuncture-Continuing-Education-News/1405-acupuncture-soothes-irritable-bowel-syndrome-ibs
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Ear Stimulation Eases IBS Pain in Teens
59% of users versus 26% of those given sham stimulation experienced a reduction in worst pain
by Diana Swift, Contributing Writer August 14, 2020
A noninvasive device (IB-Stim) delivering percutaneous electrical nerve field stimulation to the external ear safely reduced abdominal pain and improved quality of life in adolescents with irritable bowel syndrome (IBS), data from a prospective double-blind study indicated.
Confirming efficacy for improving abdominal pain in functional gastrointestinal disorders observed in an earlier study, the current IBS-focused analysis of trial data found that the percutaneous electrical nerve field stimulation (PENFS) device, worn behind the ear, led to reductions of 30% or more in worst abdominal pain in 59% of young patients compared with 26% of patients who received sham stimulation (P=0.024), reported Katja Kovacic, MD, of the division of pediatric gastroenterology, hepatology and nutrition at Medical College of Wisconsin in Milwaukee, and colleagues.
PENFS recipients had a composite pain median score of 7.5 (interquartile range [IQR] 3.6-14.4) versus 14.4 for the sham group (IQR 4.5-39.2; P=0.026) and a usual pain median score of 3.0 (IQR 3.0-5.0) versus 5.0 in the sham group (IQR 3.0-7.0; P=0.029), they noted in Clinical Gastroenterology and Hepatology.
Furthermore, a symptom response scale score of 2 or more was observed in 82% of patients receiving PENFS versus 26% of sham stimulation recipients (P≤0.001), and no significant side effects were reported.
"This study confirms that auricular neurostimulation via PENFS significantly improves abdominal pain and global symptoms in affected adolescents," wrote Kovacic and colleagues.
They noted that the results from this first prospective trial of PENFS in IBS are clinically relevant in light of the poor efficacy of pharmacological therapies for children with functional abdominal pain disorders and the dearth of safer treatment options. They argued that the device, recently approved by the FDA for IBS pain in children ages 11 to 18, should also be considered for use in adults, noting that peripheral neurostimulation has gained attention for its noninvasive modulation of central pain pathways via stimulation of peripheral cranial neurovascular bundles in the external ear.
Gastroenterologist William Chey, MD, of the University of Michigan at Ann Arbor, called neurostimulation an exciting new treatment modality for patients with functional gastrointestinal disorders.
"We've been engaging in neuromodulation for many years using drugs like tricyclics, selective serotonin reuptake inhibitors, and selective norepinephrine reuptake inhibitors, as well as via behavioral techniques like cognitive behavioral therapy and self-directed hypnosis," he told MedPage Today. "Thus, the concept of neuromodulation is not new and, indeed, has already been validated using these medications and psychological therapies."
"We also know that neurostimulation works for a number of somatic pain disorders," said Chey, who was not involved in the study.
In his view, the study adds "persuasive evidence" to a growing body of literature supporting a role of neurostimulation for the treatment of visceral pain. "I agree with the authors that studies in adults with painful conditions like IBS are warranted," he added, noting that his colleague Jiande Chen, PhD, had recently obtained funding from the National Institutes of Health for such testing. "We will be starting a series of studies to better understand the benefits of neurostimulation as a treatment for pain and other symptoms in adults with IBS."
A noninvasive device (IB-Stim) delivering percutaneous electrical nerve field stimulation to the external ear safely reduced abdominal pain and improved quality of life in adolescents with irritable bowel syndrome (IBS), data from a prospective double-blind study indicated.
Confirming efficacy for improving abdominal pain in functional gastrointestinal disorders observed in an earlier study, the current IBS-focused analysis of trial data found that the percutaneous electrical nerve field stimulation (PENFS) device, worn behind the ear, led to reductions of 30% or more in worst abdominal pain in 59% of young patients compared with 26% of patients who received sham stimulation (P=0.024), reported Katja Kovacic, MD, of the division of pediatric gastroenterology, hepatology and nutrition at Medical College of Wisconsin in Milwaukee, and colleagues.
PENFS recipients had a composite pain median score of 7.5 (interquartile range [IQR] 3.6-14.4) versus 14.4 for the sham group (IQR 4.5-39.2; P=0.026) and a usual pain median score of 3.0 (IQR 3.0-5.0) versus 5.0 in the sham group (IQR 3.0-7.0; P=0.029), they noted in Clinical Gastroenterology and Hepatology.
Furthermore, a symptom response scale score of 2 or more was observed in 82% of patients receiving PENFS versus 26% of sham stimulation recipients (P≤0.001), and no significant side effects were reported.
"This study confirms that auricular neurostimulation via PENFS significantly improves abdominal pain and global symptoms in affected adolescents," wrote Kovacic and colleagues.
They noted that the results from this first prospective trial of PENFS in IBS are clinically relevant in light of the poor efficacy of pharmacological therapies for children with functional abdominal pain disorders and the dearth of safer treatment options. They argued that the device, recently approved by the FDA for IBS pain in children ages 11 to 18, should also be considered for use in adults, noting that peripheral neurostimulation has gained attention for its noninvasive modulation of central pain pathways via stimulation of peripheral cranial neurovascular bundles in the external ear.
Gastroenterologist William Chey, MD, of the University of Michigan at Ann Arbor, called neurostimulation an exciting new treatment modality for patients with functional gastrointestinal disorders.
"We've been engaging in neuromodulation for many years using drugs like tricyclics, selective serotonin reuptake inhibitors, and selective norepinephrine reuptake inhibitors, as well as via behavioral techniques like cognitive behavioral therapy and self-directed hypnosis," he told MedPage Today. "Thus, the concept of neuromodulation is not new and, indeed, has already been validated using these medications and psychological therapies."
"We also know that neurostimulation works for a number of somatic pain disorders," said Chey, who was not involved in the study.
In his view, the study adds "persuasive evidence" to a growing body of literature supporting a role of neurostimulation for the treatment of visceral pain. "I agree with the authors that studies in adults with painful conditions like IBS are warranted," he added, noting that his colleague Jiande Chen, PhD, had recently obtained funding from the National Institutes of Health for such testing. "We will be starting a series of studies to better understand the benefits of neurostimulation as a treatment for pain and other symptoms in adults with IBS."
For his part, pediatric gastroenterologist Marc Rhoads, MD, of McGovern Medical School at UTHealth in Houston, who was not involved in the research, noted that IBS and other chronic abdominal pain disorders affect about 10% of all children older than age 5, "so this is an important issue. If the cost of the device was less than $1,000, many middle-to-upper-class families would gladly pay for it, because the pain can become dominant and disabling. I doubt that insurance would pay for it."
Study Details
Data were extracted from a prospective study of 115 largely Caucasian adolescents recruited from a tertiary care pediatric gastroenterology clinic from June 2015 to November 2016.
The mean age in the PENFS arm (n=27) and the sham arm (n=23) was just over 15 years; 89% and 91%, respectively, were female. Mixed-type IBS subtype predominated in the intervention group (63%), while IBS-constipation was the most common subtype in the sham group (43%). The primary endpoint was the number of patients with >30% decrease in worst abdominal pain severity after 3 weeks of therapy.
The number needed to treat for one patient to reach the primary endpoint was three. At the extended follow-up 8 to 12 weeks after end of therapy, 32% of the treatment group continued to have improvement of at least 30% from baseline in worst pain compared with 18% of the sham group, but this difference was not significant (P=0.33).
According to the authors, future studies should focus on characterizing short- and long-term responses to PENFS in different IBS subtypes and other functional gastrointestinal disorders, identifying the optimal duration of therapy and also assessing changes in stool patterns. In addition, mechanistic studies are needed to help target this therapy to the most appropriate patient population, including adults.
Among the study's limitations, the investigators noted the relatively small sample size in the subanalysis and a design not intended to evaluate long-term efficacy. Another limitation was the incomplete assessment of stool frequency and consistency as prespecified outcomes in accordance with FDA and European Medicines Agency recommendations.
Furthermore, although stimulation parameters were below sensation threshold, some patients may still have been able to perceive the stimulation. Additionally, the findings may not be generalizable to less complex IBS patients than those in the study cohort.
Last Updated August 17, 2020
Primary Source
Clinical Gastroenterology and Hepatology
Source Reference: Krasaelap A, et al "Efficacy of auricular neurostimulation in adolescents with irritable bowel syndrome in a randomized, double-blind trial" Clin Gastroenterol Hepatol 2020; DOI: 10.1016/j.cgh.2019.10.012.
https://www.medpagetoday.com/gastroenterology/irritablebowelsyndrome/88088
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Heather is the Administrator of the IBS Message Boards. She is the author of Eating for IBS and The First Year: IBS, and the CEO of Heather's Tummy Care. Join her IBS Newsletter. Meet Heather on Facebook!
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